GEROCILAN 5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Gerocilan, 5 mg, film-coated tablets
   1. Table of contents of the leaflet
3. What is Gerocilan and what is it used for
4. Important information before taking Gerocilan
   1. When not to take Gerocilan:
   2. Warnings and precautions
   3. Children and adolescents
   4. Gerocilan and other medicines
   5. Gerocilan with food and alcohol
   6. Fertility
   7. Driving and using machines
   8. Gerocilan contains lactose:
5. How to take Gerocilan
   1. Treatment of erectile dysfunction
   2. Treatment of symptoms of benign prostatic hyperplasia
   3. Use of a higher than recommended dose of Gerocilan
   4. Missing a dose of Gerocilan
6. Possible side effects
   1. Reporting side effects
7. How to store Gerocilan
8. Contents of the packaging and other information
   1. What Gerocilan 5 mg contains
   2. What Gerocilan 5 mg looks like and contents of the pack
   3. Marketing authorisation holder
   4. Manufacturer
   5. For more information, the patient should contact the representative of the marketing authorisation holder:
   6. Date of last revision of the leaflet: 06.12.2023

Leaflet attached to the packaging: patient information

Gerocilan, 5 mg, film-coated tablets

Tadalafil
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Gerocilan and what is it used for
• 2. Important information before taking Gerocilan
• 3. How to take Gerocilan
• 4. Possible side effects
• 5. How to store Gerocilan
• 6. Contents of the packaging and other information

1. What is Gerocilan and what is it used for

Gerocilan contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Gerocilan 5 mg is used to treat adult men with:

• erectile dysfunction.This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for sexual intercourse. After sexual stimulation, Gerocilan helps to widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, the erection improves. Gerocilan does not help patients who do not have erectile dysfunction. It is essential to be aware that Gerocilan does not work without sexual stimulation. The patient and his partner should engage in foreplay, just like when the patient is not taking erectile dysfunction medication.
• symptoms of benign prostatic hyperplasia.This is a condition where the prostate gland enlarges with age. Symptoms include: difficulty starting to urinate, feeling of incomplete emptying of the bladder, and frequent urination, even at night. Tadalafil improves blood flow and causes relaxation of the prostate and bladder muscles, which can alleviate the symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms within 1-2 weeks of starting treatment.

2. Important information before taking Gerocilan

When not to take Gerocilan:

• if the patient is allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking organic nitrates in any form or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain").

It has been shown that tadalafil enhances the effect of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor.

• if the patient has severe heart disease or has had a heart attack in the last 90 days.
• if the patient has had a stroke in the last 6 months.
• if the patient has low blood pressure or uncontrolled high blood pressure.
• if the patient has ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "eye stroke".
• if the patient is taking riociguat. This is a medicine used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as tadalafil, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions

Before starting to take Gerocilan, the patient should discuss it with their doctor.
The patient should be aware that sexual activity is associated with a risk for patients with heart disease, as it puts an additional strain on the heart. If the patient experiences heart problems, they should inform their doctor.
Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so the doctor will perform a check for prostate cancer before starting treatment with Gerocilan for benign prostatic hyperplasia symptoms.
Gerocilan is not intended for the treatment of prostate cancer.
The patient should inform their doctor if they have any of the following conditions:

• sickle-cell anaemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukaemia (blood cell cancer).
• any penile deformity.
• severe liver disease.
• severe kidney disease.

It is not known if Gerocilan is effective in patients who have had:

• pelvic surgery.
• prostate removal (prostatectomy) where the nerves of the prostate are cut (radical prostatectomy without nerve sparing).

If the patient experiences sudden vision loss or sudden hearing loss, or distorted vision, they should stop taking Gerocilan and contact their doctor immediately.
Some patients taking tadalafil have reported a decrease or sudden loss of hearing. Although it is not known if this event is directly related to the use of tadalafil, if the patient experiences a decrease or sudden loss of hearing, they should stop taking Gerocilan and contact their doctor immediately.
Gerocilan is not intended for use in women.

Children and adolescents

Gerocilan is not intended for use in children and adolescents under 18 years of age.

Gerocilan and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Gerocilan should not be taken if the patient is taking nitrates.
Gerocilan may affect the action of some medicines or other medicines may affect the action of Gerocilan. The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or symptoms of benign prostatic hyperplasia).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole in tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Gerocilan with food and alcohol

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Gerocilan, so caution should be exercised when consuming it. For more information, the patient should consult their doctor.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes was observed. A decrease in sperm concentration was observed in some men. It is unlikely to lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness, so the patient should be aware of their reaction to the tablets before driving or operating machinery.

Gerocilan contains lactose:

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Gerocilan

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.
Gerocilan tablets are for oral use only in men. The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food.
Consuming alcohol may cause a temporary decrease in blood pressure. If the patient has taken Gerocilan or plans to take it, they should not consume large amounts of alcohol (blood alcohol concentration 0.08% or higher), as this may increase the risk of dizziness when standing up.

Treatment of erectile dysfunction

The recommended dose is one 5 mg tablet, taken once a day, at approximately the same time of day. The doctor may change the dose to 2.5 mg, depending on the patient's response to Gerocilan.
The patient should take a 2.5 mg tablet.
Gerocilan should not be taken more than once a day.
Taking Gerocilan once a day allows for the achievement of an erection after sexual stimulation at any time of the day.
Taking Gerocilan once a day may be beneficial for men who intend to engage in sexual activity twice a week or more often.
It is essential to be aware that Gerocilan does not work without sexual stimulation.
The patient and their partner should engage in foreplay, just like when the patient is not taking erectile dysfunction medication.
Consuming alcohol may affect the patient's ability to achieve an erection.

Treatment of symptoms of benign prostatic hyperplasia

The dose is one 5 mg tablet, taken once a day, at approximately the same time of day. If the patient has benign prostatic hyperplasia and erectile dysfunction, the dose of one 5 mg tablet per day remains unchanged.
Gerocilan should not be taken more than once a day.

Use of a higher than recommended dose of Gerocilan

The patient should inform their doctor. Adverse reactions may occur, as described in section 4.

Missing a dose of Gerocilan

The patient should take the missed dose as soon as they remember, but they should not take a double dose to make up for the missed tablet.
Gerocilan should not be taken more than once a day.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects are usually mild or moderate.
If the patient experiences any of the following side effects, they should stop taking the medicine and contact their doctor immediately:

• allergic reactions, including skin rash (not very common).
• chest pain - the patient should not take nitrates, but should seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erections after taking Gerocilan (rare). If such an erection occurs and lasts continuously for more than 4 hours, the patient should contact their doctor immediately.
• sudden vision loss (rare), distorted vision, blurred vision, or sudden worsening of vision (frequency not known).

Other reported side effects:

Common(occurring in less than 1 in 10 patients)

• headache, back pain, muscle pain, pain in arms and legs, flushing, nasal congestion, and indigestion.

Uncommon(occurring in less than 1 in 100 patients)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the face, feet, or ankles, and feeling tired.

Rare(occurring in less than 1 in 1000 patients)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, hives (itchy, red, raised patches on the skin), bleeding from the nose, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before starting to take this medicine.
There have been reports of rare cases of partial, temporary, or permanent loss of vision or blindness in one or both eyes.
Men taking tadalafil have reported several additional rare side effects that were not observed during clinical trials, including:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• distorted vision, blurred vision, or sudden worsening of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea was reported more frequently in men over 65 years of age taking tadalafil.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Gerocilan

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the packaging and other information

What Gerocilan 5 mg contains

• The active substance of the medicine is tadalafil. Each tablet contains 5 mg of tadalafil.
• Excipients:

Tablet core:
Lactose
Croscarmellose sodium
Sodium lauryl sulfate
Hydroxypropyl cellulose
Polysorbate 80
Magnesium stearate
Coating:
Hypromellose 2910
Lactose monohydrate
Titanium dioxide (E 171)
Triacetin
Talc
Yellow iron oxide (E 172)

What Gerocilan 5 mg looks like and contents of the pack

Yellow, biconvex, film-coated tablet in the shape of an oval, with the inscription "T 5" on one side and smooth on the other.
PVC/PVDC/Aluminium blisters in a cardboard box. The pack contains 1, 2, 4, 8, 10, 12, 14, 20, 28, 30, 40, 50, 56, 60, 84, 90, 98, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Genepharm S.A.
Marathonos Avenue 18 Th Km.
15351 Pallini, Attiki
Greece
Combino Pharm (Malta) Ltd.
HF 60, Hal Far Industrial Estate
BBG 3000 Birzebbuga
Malta
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Estate
PLA 3000 Paola
Malta

For more information, the patient should contact the representative of the marketing authorisation holder:

G.L. PHARMA POLAND Sp. z o.o.
Jana Pawła II Avenue 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: 06.12.2023